Required Skills and Experience:
- Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing
- Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support.
- Strong problem-solving skills, root cause analysis and risk assessment/mitigation
- Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results
- A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required.
- Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
- Must be able to work under own initiative, prioritise appropriately based on business need and work within tight deadlines.
- Flexibility and the ability to work independently as well as excellent organizational skills.
- Strong knowledge of quality systems, drug substance manufacturing and validation.
- Excellent command of English (both written and oral).
- Travel will be a requirement of this position at approximately 25%
Preferred Experience and Skills:
- Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential.
- Lean Manufacturing / Six Sigma Experience
- Project management experience
- Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
